Surgical Instrument Including MEMS Devices

ABSTRACT

Surgical instruments are disclosed that are couplable to or have an end effector or a disposable loading unit with an end effector, and at least one micro-electromechanical system (MEMS) device operatively connected to the surgical instrument for at least one of sensing a condition, measuring a parameter and controlling the condition and/or parameter.

CROSS-REFERENCE TO RELATED APPLICATION

The present application claims the benefit of and priority to U.S.Provisional Application Ser. No. 60/375,495 and U.S. ProvisionalApplication Ser. No. 60/375,496, both of which were filed on Apr. 25,2002, and the entire disclosures of which are incorporated herein byreference.

BACKGROUND

1. Technical Field

The present disclosure relates to surgical instruments and, moreparticularly to mechanical, electro-mechanical and energy based surgicalinstruments and systems.

The present disclosure relates generally to surgical instruments andsystems and, more specifically, to surgical stapler instruments andsystems and energy based instruments and systems, havingmicro-electromechanical system (MEMS) devices for sensing, monitoring,controlling, measuring and/or regulating conditions and/or parametersassociated with the performance of various surgical procedures.

2. Background of Related Art

Surgical instruments used in open and minimally invasive surgery arelimited in their ability to sense and/or control conditions and/orparameters and factors critical to effective operation. For example,conventional surgical instruments cannot measurably detect the amount oftissue positioned between tissue contacting surfaces of an end effectorof the surgical instrument.

Micro-electromechanical systems (MEMS) are integrated micro devices orsystems combining electrical and mechanical components. They arefabricated using integrated circuitry (i.e., I.C.) batch processingtechniques and can range in size from micrometers to millimeters. Thesemicro-electromechanical systems sense, control and/or actuate on themicro scale, and function individually or in arrays to generate effectson the macro scale.

In general, MEMS devices are complex systems which individually includeone or more electrical systems and/or one or more micro-mechanicalsystems. The micro-mechanical systems are fabricated using many of thesame fabrication techniques that have miniaturized electronic circuitsand made mass production of silicon integrated circuit chips possible.In particular, MEMS devices include mechanical micro-structures;micro-sensors, micro-actuators and electronics integrated in the sameenvironment (i.e., on a silicon chip) by using micro-fabricationtechnology. Micro-fabrication technology enables fabrication of largearrays of devices, which individually perform simple tasks but incombination can accomplish complicated functions.

MEMS devices are advantageous for many reasons. In particular, MEMSdevices can be so small that hundreds can be fit in the same space,which perform the same or many different functions, as compared to asingle macro-device, which performs a single function. Moreover, usingI.C. batch processing techniques, hundreds to thousands of these MEMSdevices can be fabricated on a single silicon wafer. This massproduction greatly reduces the price of individual devices. Thus, MEMSdevices are relatively less expensive than their macro-worldcounterparts. In addition, cumbersome electrical components aretypically not needed with MEMS devices, since the electronics can beplaced directly on the MEMS device. This integration also has theadvantage of picking up less electrical noise, thus improving theprecision and sensitivity of sensors. As discussed above, MEMS devicesprovide some of the functionality of analytical instrumentation, butwith vastly reduced cost, size, and power consumption, and an abilityfor real-time, in situ measurement.

Examples of micro-electromechanical systems are disclosed in U.S. Pat.No. 6,127,811 to Shenoy et al.; U.S. Pat. No. 6,288,534 to Starkweatheret al.; U.S. Pat. No. 6,092,422 to Binnig et al.; U.S. PatentApplication No. US 2001/0020166 PCT filed Apr. 30, 1997; Microtechnologyin Modern Health Care by P. Detemple, W. Ehrfeld, H. Freimuth, R.Pommersheim, and P. Wagler in Medical Device Technology, November 1998;and Microelectromechanical Systems (MEMS): Technology, Design andApplications, coordinator: Lee, Abraham, University of California, LosAngeles, Department of Engineering, Information Systems and TechnicalManagement, Short Course Program, Engineering 823.53, May 19-22, 1997,the entire contents of each of which are incorporated herein byreference.

Accordingly, a need exists for surgical instruments that can sense amultitude of parameters and factors, such as, for example, the distancebetween the tissue contacting surfaces of the surgical instrument. Sucha surgical instrument can, according to the conditions sensed and/ormeasured, utilize, display, record and/or automatically control theposition of the tissue contacting surfaces of the surgical instrument oralert a surgeon prior to operation of the surgical instrument.

In view of the foregoing, the need exists for the use ofmicro-electromechanical systems in combination with the surgicalinstruments and systems and, in particular in stapling instruments andenergy based surgical instruments for monitoring, controlling andregulating conditions and/or parameters associated with the performanceof various mechanical, electro-mechanical and electrosurgicalprocedures.

SUMMARY

The present invention is direct to surgical instruments including an endeffector configured and adapted to engage tissue, and at least onemicro-electromechanical system (MEMS) device operatively connected tothe surgical instrument for at least one of sensing a condition,measuring a parameter and controlling the condition and/or parameteradjacent the end effector. The at least one MEMS device is operativelyconnected to the end effector. The at least one MEMS device is at leastone of a pressure sensor, a strain sensor, a displacement sensor, anoptical sensor, a biosensor, a temperature sensor, a torque sensor, anaccelerometer, a flow sensor, an electrical sensor and a magnetic sensorfor at least one of sensing, measuring and controlling the associatedcondition and/or parameter.

It is contemplated that the surgical instrument is a surgical staplerand the end effector includes a staple cartridge assembly, and an anviloperatively associated with the staple cartridge, the staple cartridgeand the anvil being movably connected to one another to bring one intojuxtaposition relative to the other. Each of the staple cartridge andthe anvil define tissue contacting surfaces and the at least one MEMSdevice is operatively connected to at least one of the tissue contactingsurface of the staple cartridge and the tissue contacting surface of theanvil. A plurality of MEMS devices are connected to the surgicalinstrument, the MEMS devices being configured and adapted to measuredistance between the tissue contacting surface of the staple cartridgeassembly and the tissue contacting surface of the anvil.

The MEMS devices can be configured and adapted to measure the amount ofpressure applied to tissue clamped between the tissue contacting surfaceof the staple cartridge and the tissue contacting surface of the anvil.The MEMS devices are configured and adapted to measure the thickness ofthe tissue clamped between the tissue contacting surface of the staplecartridge and the tissue contacting surface of the anvil.

It is envisioned that the end effector is configured and adapted toperform an anastomosis. The surgical instrument can be a linear staplerthat is adapted to perform an endoscopic gastrointestinal anastomosis.It is further contemplated that the surgical instrument is an annularstapler that is adapted to perform an end-to-end anastomosis.

It is envisioned that the end effector is a jaw mechanism including apair of jaw members pivotably coupled to the distal end of the elongateshaft. It is further envisioned that at least one MEMS device isprovided on at least one of the pair of jaw members. The MEMS devicesare provided at least at one of a proximal end, a distal end and along alength of each of the pair of jaw members.

It is envisioned that the jaw mechanism is configured and adapted toperform an electrosurgical function. The jaw mechanism is configured andadapted to deliver electrosurgical energy to a target surgical site.

It is further envisioned that the surgical instrument is operativelycouplable to a robotic system, wherein the end effector is configuredand adapted to be remotely operated by the robotic system.

It is contemplated that the surgical instrument can include a loadingunit having a proximal end and a distal end, the proximal end beingselectively removably connected to the surgical instrument, the endeffector is operatively connected to and part of the loading unit, andthe loading unit includes the at least one MEMS device.

The end effector can be a surgical stapler including a staple cartridgeassembly, and an anvil operatively associated with the staple cartridgeassembly, the staple cartridge assembly and the anvil being movable andjuxstaposable relative to one another. Each of the staple cartridgeassembly and the anvil define tissue contacting surfaces and wherein atleast one MEMS device is operatively connected to the at least one ofthe tissue contacting surface of the staple cartridge assembly and thetissue contacting surface of the anvil.

The MEMS devices are configured and adapted to measure distance betweenthe tissue contacting surface of the staple cartridge assembly and thetissue contacting surface of the anvil. The MEMS devices are configuredand adapted to measure at least one of the amount of pressure applied totissue and the thickness of tissue clamped between the tissue contactingsurface of the staple cartridge assembly and the tissue contactingsurface of the anvil.

The loading unit can include an elongate shaft having a distal end, theend effector being operatively connected to a distal end of an elongateshaft and the staple cartridge and the anvil are oriented transverselywith respect to the elongate shaft.

It is envisioned that the end effector is configured and adapted toperform an anastomosis. It is further envisioned that the end effectoris a jaw mechanism including a pair of jaw members pivotably coupled tothe distal end of the elongate shaft. The at least one MEMS device isprovided on at least one of the pair of jaw members. The MEMS devicescan be provided at least at one of a proximal end, a distal end andalong a length of each of the pair of jaw members.

It is envisioned that the jaw mechanism is configured and adapted toperform an electrosurgical function. The jaw mechanism can be configuredand adapted to deliver electrosurgical energy to the target surgicalsite.

It is envisioned that each of the plurality of MEMS devices iselectrically connected to a control box via a lead wire extending fromthe housing.

The surgical instrument can further include a control box electricallyconnected to each of the plurality of MEMS devices via at least one wirelead.

According to another aspect of the present invention, there is provideda robotic system for performing surgical tasks a frame, a robotic armconnected to the frame and movable relative to the frame, an actuationassembly operatively associated with the robotic arm for controllingoperation and movement of the robotic arm, a loading unit including anelongate shaft operatively connected to the robotic arm, and an endeffector operatively coupled to a distal end of the elongate shaft andconfigured to engage tissue, and at least one micro-electromechanicalsystem (MEMS) device operatively connected to the loading unit for atleast one of sensing a condition, measuring a parameter and controllingthe condition and/or parameter adjacent the end effector.

The at least one MEMS device is at least one of a pressure sensor, astrain sensor, a displacement sensor, an optical sensor, a biosensor, atemperature sensor, a torque sensor, an accelerometer, a flow sensor, anelectrical sensor and a magnetic sensor for at least one of sensing,measuring and controlling an associated condition and/or parameter.

In one embodiment the end effector includes a pair of jaw membersmovably coupled to the distal end of the elongate shaft. It isenvisioned that a plurality of MEMS devices are provided on each of thepair of jaw members. Preferably, a plurality of MEMS devices areprovided at least at one of a proximal end, a distal end and along alength of each of the pair of jaw members.

The loading unit can be connected to the robotic arm via a bayonet-typeconnection.

In another embodiment, the end effector is configured and adapted toperform an electrosurgical function. Preferably, the end effector isconfigured and adapted to deliver electrosurgical energy to the targetsurgical site.

In yet another embodiment, the robotic system further includes acontroller having a processor and a receiver for receiving electricalsignals transmitted from the actuation assembly and for controlling theoperation and movement of the loading unit.

The end effector can be a fastener applier, a surgical stapler, a vesselclip applier or a vascular suturing assembly.

As a surgical stapler, the end effector includes a staple cartridgeassembly and an anvil operatively associated with the staple cartridgeassembly and in juxtaposition relative to the staple cartridge assembly,and wherein at least one MEMS device is operatively connected to each ofthe staple cartridge assembly and the anvil. The staple cartridgeassembly defines a tissue contacting surface and wherein at least oneMEMS device is operatively connected to the tissue contacting surface ofthe staple cartridge assembly. The anvil defines a tissue contactingsurface and wherein at least one MEMS device is operatively connected tothe tissue contacting surface of the staple cartridge.

The MEMS devices can be configured and adapted to measure distancebetween the tissue contacting surface of the staple cartridge assemblyand the tissue contacting surface of the anvil. Alternatively, the MEMSdevices can be are configured and adapted to measure the amount ofpressure applied to tissue clamped between the tissue contacting surfaceof the staple cartridge assembly and the tissue contacting surface ofthe anvil.

The staple cartridge assembly and the anvil are desirably transverselyoriented with respect to the elongate shaft. It is envisioned that thestaple cartridge assembly and the anvil are pivotably connected to thedistal end of the elongate shaft.

As a vessel clip applier, the end effector includes a body portionhaving a distal end and a proximal end, wherein the proximal end isoperatively connectable to the robotic arm, and a jaw assemblyoperatively connected to the distal end of the body portion, wherein thejaw assembly includes a first and a second jaw portion. Each of thefirst and the second jaw portions includes at least one MEMS deviceoperatively connected thereto.

As a vascular suturing assembly, the end effector includes an elongatebody having a distal end and a proximal end, wherein the proximal end inoperatively connectable to the robotic arm, and a pair of needlereceiving jaws pivotably mounted to the distal end of the elongate bodyportion, the pair of needle receiving jaws being configured and adaptedto pass a surgical needle and associated length of suture materialtherebetween. Preferably, at least one MEMS component is operativelyconnected to each of the pair of needle receiving jaws.

According to yet another aspect of the present invention a loading unitfor use with a surgical instrument is provided and includes an elongatetubular shaft having a proximal end and a distal end, an end effectoroperably connected to the distal end of the tubular shaft, a connectorfor connecting the proximal end of the tubular shaft to a surgicalinstrument, and at least one micro-electromechanical system (MEMS)device operatively connected to the loading unit for at least one ofsensing a condition, measuring a parameter and controlling the conditionand/or parameter adjacent the end effector.

It is envisioned that at least one MEMS device is operatively connectedto the end effector. The MEMS device can be at least one of a pressuresensor, a strain sensor, a displacement sensor, an optical sensor, abiosensor, a temperature sensor, a torque sensor, an accelerometer, aflow sensor, an electrical sensor and a magnetic sensor for at least oneof sensing, measuring and controlling an associated condition and/orparameter.

It is contemplated that the surgical instrument is a surgical staplerand the end effector includes a staple cartridge assembly and an anviloperatively associated with the staple cartridge, the staple cartridgeand the anvil being movably connected to one another to bring one intojuxtaposition relative to the other. Each of the staple cartridge andthe anvil define tissue contacting surfaces and the at least one MEMSdevice is operatively connected to at least one of the tissue contactingsurface of the staple cartridge and the tissue contacting surface of theanvil.

It is envisioned that a plurality of MEMS devices connected to thesurgical instrument, the MEMS devices being configured and adapted tomeasure distance between the tissue contacting surface of the staplecartridge assembly and the tissue contacting surface of the anvil. It isfurther envisioned that the MEMS devices are configured and adapted tomeasure the amount of pressure applied to tissue clamped between thetissue contacting surface of the staple cartridge and the tissuecontacting surface of the anvil. It is still further envisioned that theMEMS devices are configured and adapted to measure the thickness of thetissue clamped between the tissue contacting surface of the staplecartridge and the tissue contacting surface of the anvil.

The end effector can be configured and adapted to perform ananastomosis. The surgical instrument can be a linear stapler that isadapted to perform an endoscopic gastrointestinal anastomosis. Thesurgical instrument can be an annular stapler that is adapted to performan end-to-end anastomosis.

It is envisioned that the end effector is a jaw mechanism including apair of jaw members pivotably coupled to the distal end of the elongateshaft. At least one MEMS device can be provided on at least one of thepair of jaw members. The MEMS devices can be provided at least at one ofa proximal end, a distal end and along a length of each of the pair ofjaw members.

It is contemplated that at least one MEMS device is a temperaturesensing MEMS device. The temperature sensing MEMS device is positionedon and/or encapsulated in thermally conductive tips or elements, whereinthe conductive tips are semi-rigid wires made of shape memory metal fora particular application, wherein the conductive tips are extendable outfrom the loading unit and into the tissue adjoining the loading unit inorder to monitor temperature of the tissue adjoining the loading unit.

According to another aspect of the present invention, a surgicalinstrument for use with a loading unit that is operatively couplable tothe surgical instrument and has an end effector with a pair ofjuxtaposable jaws for performing a surgical function, the end effectorhaving at least one micro-electromechanical system (MEMS) deviceoperatively connected thereto for at least one of sensing a condition,measuring a parameter and controlling the condition and/or parameteradjacent the end effector. The surgical instrument includes a housing,an elongate shaft that extends from the housing and has a distal endoperatively couplable to a loading unit of the above type, anapproximation mechanism for approximating the pair of jaws, an actuationmechanism for activating the jaws to perform the surgical function, andat least one micro-electromechanical system (MEMS) device operativelyconnected to the surgical instrument for at least one of sensing acondition, measuring a parameter and controlling the condition and/orparameter adjacent the end effector and for cooperative operation withthe at least one MEMS of the end effector.

It is an object of the present disclosure to provide mechanical,electro-mechanical and energy based surgical instruments and systemshaving micro-electromechanical devices associated therewith to monitor,control, measure and/or regulate conditions and parameters associatedwith the performance and operation of the surgical instrument.

It is a further object of the present disclosure to provide improvedmechanical, electro-mechanical and energy based surgical instruments andsystems which are more effective, safer and/or easier to use thansimilar conventional surgical instruments and systems.

It is another object of the present disclosure to provide improvedmechanical, electro-mechanical and energy based surgical instruments andsystems which better control the effects they have on target tissue andon the patient.

These and other objects will be more clearly illustrated below by thedescription of the drawings and the detailed description of thepreferred embodiments.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the presentdisclosure and, together with the detailed description of theembodiments given below, serve to explain the principles of thedisclosure.

FIG. 1 is a perspective view of a surgical stapling instrumentincorporating micro-electromechanical system devices, in accordance withthe present disclosure;

FIG. 2 is a partially exploded perspective view of an alternativesurgical stapling instrument incorporating micro-electromechanicalsystem devices in accordance with the present disclosure;

FIG. 3 is a perspective view of yet another surgical stapling instrumentincorporating micro-electromechanical system devices in accordance withthe present disclosure;

FIG. 3A is an enlarged perspective view of a distal end of the surgicalstapling instrument of FIG. 3;

FIG. 4 is a perspective view of still another surgical staplinginstrument incorporating micro-electromechanical system devices inaccordance with the present disclosure;

FIG. 5 is a perspective view of a surgical instrument for placing clipsin laparoscopic or endoscopic procedures incorporatingmicro-electromechanical system devices in accordance with the presentdisclosure;

FIG. 5A is an enlarged perspective view of the indicated region of thesurgical instrument depicted in FIG. 5;

FIG. 6 is a perspective view of an energy-based surgical instrumentincorporating micro-electromechanical system devices in accordance withthe present disclosure;

FIG. 6A is an enlarged perspective view of the indicated region of thesurgical instrument depicted in FIG. 6;

FIG. 7 is a perspective view of a robotic system that employsmicro-electromechanical system devices in accordance with the presentdisclosure;

FIG. 8 is a block diagram illustrating the components of a disposableloading unit in accordance with the present disclosure;

FIG. 9 is a perspective view, with portions broken away, of a roboticsystem coupled to a loading unit, including an end effector for applyingsurgical staples;

FIG. 10 is a perspective view, with portions broken away, of a roboticsystem coupled to a loading unit, including an end effector for applyingelectrosurgical energy;

FIG. 11 is a perspective view, with portions broken away, of a roboticsystem coupled to a loading unit, including an end effector for applyingvessel clips; and

FIG. 12 is a perspective view, with portions broken away, of a roboticsystem coupled to a loading unit, including an end effector for applyinga vascular suture.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

Preferred embodiments of the presently disclosed surgical instrumentsand systems will now be described in detail with reference to thedrawing figures wherein like reference numerals identify similar oridentical elements. As used herein and as is traditional, the term“distal” will refer to that portion which is further from the user whilethe term “proximal” will refer to that portion which is closer to theuser.

In accordance with the present disclosure, a micro-electromechanicalsystem (MEMS) is used to provide highly miniaturized MEMS devices and/orsystems capable of performing various functions, e.g., sensing,monitoring, controlling, influencing, regulating and/or measuringvarious conditions and/or parameters of surgical instruments andsystems, such as, for example, the distance between and/or the pressureapplied by the jaws of an end effector. In the present disclosure,“controlling” is meant to include influencing and/or regulating. TheMEMS devices and/or systems can also provide feedback for automatic(remote or manual) control of the operation of the surgical instrument.

MEMS devices have the required very small size, low power requirements,and ability to be readily integrated with standard electrical systems.These characteristics make MEMS devices ideal for incorporation intoand/or on surgical instruments and systems. As will be described ingreater detail below, MEMS devices can be utilized in conjunction with,and incorporated into and/or on various portions and structural elementsof surgical instruments and systems.

MEMS devices and/or systems considered to be within the scope of thepresent disclosure, include, for example, MEMS sensors and/or sensordevices, actuator MEMS devices (motors, hydraulics, pumps, ultrasonicdevices, etc.), fluid moving and mixing components, heaters, anddiagnostic MEMS devices for measuring physiologic parameters and tissueproperties, such as the integrity of a staple line or of a repaired orjoined tissue by measuring fluid, e.g., blood flow and/or presence, andelectrical signals or pressure within the stapled tissue.

Also considered within the scope of this disclosure are: types of MEMSdevices and/or systems used to determine and/or measure distanceincluding capacitive, magnetic (Hall Effect sensors, for measuring thestrength of the magnetic field between one or more magnets), light orradio frequency (RF) emitting/receiving, and optical fiberinterferometric sensors; types of MEMS devices and/or systems used todetermine and/or measure the amount of pressure applied to tissueincluding capacitive, piezoelectric, piezoresistive, resonant, light orRF emitting/receiving, and optical fiber interferometric sensors; andtypes of MEMS devices and/or systems used to determine and/or measuretissue thickness, and to determine or measure pressure and/or to providepressure data to a processor which correlates the pressure data withtissue thickness using a look-up table or other data structure. Byknowing the tissue thickness, the surgeon can then determine the propersize of the staples and/or tissue gap between the tissue contactingsurfaces of the anvil and staple cartridge before performing thestapling procedure.

While MEMS devices and/or systems are preferred, it is within the scopeof the present disclosure and envisioned that other types of devicesand/or systems can be used with or without MEMS devices and/or systemsto determine and/or measure various conditions and/or parameters.

In a preferred configuration, the surgical instrument can include one ormore transducer MEMS delivery devices and/or systems capable of beingpowered by a battery for generating RF or other types of signals. Thesetransducer MEMS delivery devices are aligned with transducer MEMSreceiving devices capable of receiving the generated signals.Accordingly, the distance between the transducer MEMS delivery andreceiving devices can be measured by a processor correlating thetransmission time of the generated RF signals with distance using a datastructure. By knowing the distance, the processor can then compute thethickness of the tissue clamped by the surgical instrument.

Further, when the transducer MEMS delivery and/or receiving devicespress upon the tissue clamped by the surgical instrument, pressure fromthe tissue is applied to the transducer MEMS delivery and/or receivingdevices and/or systems. The transducer MEMS delivery and/or receivingdevices and/or systems in turn determine the applied pressure and outputsignals.

Alternatively, one or more transducer MEMS delivery and/or receivingcomponents, capable of generating and receiving signals reflected off atarget, can be provided on the anvil and/or the staple cartridge inorder to determine the distance between the tissue contacting surfacesof the anvil and the staple cartridge for determining if the staplecartridge should be fired.

Preferably, circuitry of the MEMS devices and/or systems amplifies thesignals, before being transmitted to standard electrical components orto the processor, for analysis using conventional algorithms implementedas a set of programmable instructions. The processor analyzes thereading to determine if the reading is within the desired limits for thesurgical instrument and/or the current application. The processor canuse at least one or more comparators to compare the value of thedetermined reading with stored, predetermined values.

If the determined reading is within the desired limits for the surgicalinstrument, then the surgical instrument can be fired as usual. However,if the reading is outside of the desired limits, the surgical instrumentand/or the operator can: (1) prevent the firing of the surgicalinstrument until the reading is within the desired limits; (2) adjustthe components of the surgical instrument in order to alter the readingas needed; (3) alert the operator; and/or (4) wait a few moments andthen take the reading again.

Further, the measured readings received from the MEMS devices and/orsystems can also be used to control the firing of the surgicalinstrument. For example, if the tissue thickness is large, the firing ofthe surgical instrument can be automatically or manually adjusted inorder for the surgical instrument to be fired with sufficient power toaffect all of the tissue. The reading of tissue thickness can also beused by a surgeon to determine whether the power applied by the surgicalinstrument is large enough to penetrate and affect all of the tissue.

The MEMS devices and/or systems are preferably positioned at opposing orjuxtaposed locations when used to measure and/or determine distances.The MEMS devices are also preferably positioned on tissue contactingsurfaces of the surgical instrument in order to measure and/or determinea distance between the tissue contacting surfaces of the surgicalinstrument as one or more structural components of the surgicalinstrument is/are moved relative to one another. It is furtherenvisioned that MEMS devices and/or systems are capable of measuringand/or determining a thickness of tissue clamped between the tissuecontacting surfaces of the surgical instrument.

Other types of MEMS devices and/or systems that can be used within thescope of the present disclosure include strain, optical, flow,electrochemical and bio-sensors. Optical sensors for fluorescence andabsorption for determining, for example, the presence of blood glucose,and hence, the presence of blood, require fiber optic connections tophotodetectors and/or photomultiplier tubes that may or may not beminiaturized. Biosensors can be used to measure tissue characteristicsbefore and/or after the stapling procedure. That is, bio-sensors can beused to ensure that the tissue is in condition or acceptable forstapling, or as a check after the staples have been fired to ensure thatthe tissue is healthy (e.g., has good blood flow, is healing properly,etc).

Turning now to FIGS. 1-4, specific embodiments of several representativesurgical staplers including MEMS devices “M”, in accordance with thepresent disclosure, are shown. As seen in FIG. 1, a first embodiment ofa surgical stapler, here, a transverse anastomotic stapler, inaccordance with the present disclosure, is shown generally as 100.Surgical stapler 100 includes a housing 112 including a stationaryhandle 114, a distally extending body portion 116 operatively connectedto housing 112, and a transverse body portion 115 operatively connectedto distally extending body portion 116. Transverse body portion 115 isconfigured and adapted to operatively receive a support frame 118 in adistal end thereof.

Surgical stapler 100 further includes an anvil 120 fastened to a firstleg 124 or distal portion of support frame 118 and extendingtransversely across transverse body portion 115. Surgical stapler 100further includes a staple cartridge assembly 122 operatively receivedwithin transverse body portion 115. Each of anvil 120 and staplecartridge assembly 122 include juxtaposed tissue contacting surfaces 120a, 122 a, respectively. A trigger actuator 134 is operatively connectedto handle 114 and is configured and adapted to distally advance staplecartridge assembly 122 toward anvil 120 in order to fire surgicalstapler 100.

In accordance with the present disclosure, surgical stapler 100 includesa plurality of MEMS devices “M” provided at specific locations thereon.In particular, by way of example only and in no way is it to beconsidered as limiting, as seen in FIG. 1, MEMS devices “M” canpreferably be provided along the length of tissue contacting surface 120a of anvil 120, along the length of tissue contacting surface 122 a ofstaple cartridge assembly 122 and/or on staple cartridge assembly 122and transverse body portion 115.

As described above, MEMS devices “M” enable, for example, themeasurement of various parameters of surgical stapler 100, such as, forexample, the distance between tissue contacting surfaces 120 a and 122 aof surgical stapler 100, as well as the amount of pressure applied totissue clamped between tissue contacting surfaces 120 a, 122 a. It isfurther envisioned that MEMS devices “M” are capable of measuring and/ordetermining a thickness of the tissue clamped between tissue contactingsurfaces 120 a, 122 a.

It is envisioned that MEMS devices “M” may transmit feedback signals ofthe measured and/or sensed parameters to a central processing unit “CPU”(e.g., control box 562 of FIG. 6) or actuation assembly 612 (see FIG.7), via wire leads 560 (see FIG. 6) or transmission wires “W” (see FIG.7), for further processing. Alternatively, it is contemplated that MEMSdevices “M” can transmit feedback signals of the measured and/or sensedparameters to the CPU via wireless transmissions.

Reference is made to commonly assigned U.S. Pat. No. 5,964,394 toRobertson, the entire content of which is incorporated herein byreference, for a more detailed explanation of the operation of surgicalstapler 100.

Turning now to FIG. 2, an alternative embodiment of a surgical stapler,here, an open gastrointestinal anastomotic stapler, in accordance withthe present disclosure, is shown generally as 200. Surgical stapler 200includes a cartridge receiving half-section 212, an anvil half-section214 operatively couplable to cartridge receiving half-section 212, astaple cartridge assembly 216 configured and adapted to be removablymounted within a distal end of cartridge receiving half-section 212, andan anvil 218 operatively mounted to a distal end of anvil half-section214. Staple cartridge assembly 216 includes a tissue contacting surface216 a and anvil 218 includes a tissue contacting surface 218 ajuxtaposed to tissue contacting surface 216 a of staple cartridgeassembly 216.

In accordance with the present disclosure, surgical stapler 200 includesa plurality of MEMS devices “M” provided at specific locations thereon.In particular, by way of example only and in no way is it to beconsidered as limiting, as seen in FIG. 2, MEMS devices “M” canpreferably be provided along the length of or as shown, at specificlocations on tissue contacting surface 218 a of anvil 218, along thelength of tissue contacting surface 216 a of staple cartridge assembly216, on the distal end portions of cartridge receiving half-section 212and anvil half-section 214.

As described above, MEMS devices “M” enable the measurement of variousparameters of surgical stapler 200, such as, for example, the distancebetween tissue contacting surfaces 216 a and 218 a of surgical stapler200, as well as the amount of pressure applied to tissue clamped betweentissue contacting surfaces 216 a, 218 a of surgical stapler 200.

Reference is made to commonly assigned U.S. Pat. No. 6,045,560 to McKeanet al., U.S. Pat. No. 6,032,849 to Mastri et al., and U.S. Pat. No.5,964,394 to Robertson, the entire contents of each of which areincorporated herein by reference, for a more detailed explanation of theoperation of surgical stapler 200.

Turning now to FIGS. 3 and 3A, yet another embodiment of a surgicalstapler, here, an endoscopic gastrointestinal anastomotic stapler, inaccordance with the present disclosure, is shown generally as 300.Briefly, surgical stapler 300 includes a handle assembly 312 and anelongated body 314. A disposable loading unit or DLU 316 is releasablysecured to a distal end of elongated body 314. Disposable loading unit316 includes an end effector 317 having a staple cartridge assembly 318housing a plurality of surgical staples (not shown) and an anvil 320movably secured in relation to staple cartridge assembly 318. Staplecartridge assembly 318 includes a tissue contacting surface 318 a andanvil 320 includes a tissue contacting surface 320 a juxtaposed totissue contacting surface 318 a of staple cartridge assembly 318.

Handle assembly 312 includes a stationary handle member 322, a movablehandle member 324 and a barrel portion 326. A rotatable member 328 ispreferably mounted on the forward end of barrel portion 326 tofacilitate rotation of elongated body 314 with respect to handleassembly 312. An articulation lever 330 is also preferably mounted onthe forward end of barrel portion 326 adjacent rotatable knob 328 tofacilitate articulation of end effector 317.

In accordance with the present disclosure, surgical stapler 300 includesa plurality of MEMS devices “M” provided at specific locations thereon.In particular, by way of example only and in no way is it to beconsidered as limiting, as seen in FIGS. 3 and 3A, MEMS devices “M” canbe provided preferably along the length of tissue contacting surface 320a of anvil 320, along the length of tissue contacting surface 318 a ofstaple cartridge assembly 318, on disposable loading unit 316, onelongated body 314 and/or on handle assembly 312.

As described above, MEMS devices “M” enable the measurement of variousparameters of surgical stapler 300, such as, for example, the distancebetween tissue contacting surfaces 318 a and 320 a of surgical stapler300, as well as the amount of pressure applied to tissue clamped betweentissue contacting surfaces 318 a, 320 a of surgical stapler 300.

In another preferred configuration, as shown in FIGS. 3 and 3A, MEMSdevices “M” are positioned in proximity to a pivot point of anvil 320and staple cartridge assembly 318 of surgical stapler 300. Other MEMSdevices “M” are positioned remotely from the pivot point. It isenvisioned that the MEMS devices “M” positioned on anvil 320 and staplecartridge assembly 318 can be of the type capable of emitting light fromlaser diodes or from a fiber optic waveguide. In particular, a MEMSdevice in the form of a MEMS light producing sensor/device (e.g., bicellor photodiode) is positioned opposite an aforementioned MEMS device fordetecting changes in the amount of light being received as a result ofthe changing angle of rotation between anvil 320 and staple cartridge318.

Accordingly, in use, if the amount of light being received is high, aMEMS light producing device and its corresponding MEMS light detectiondevice are close to each other. Accordingly, the distance between anvil320 and staple cartridge assembly 318 is small, and, if there is anytissue clamped between anvil 320 and staple cartridge assembly 318, thethickness of the tissue is also small. If the amount of light beingreceived is low, the MEMS light producing device and its correspondingMEMS light detection device are further from each other. Accordingly,the distance between anvil 320 and staple cartridge assembly 318 islarge, and, if there is any tissue clamped between anvil 320 and staplecartridge assembly 318, the thickness of the tissue is also large.

Distance and tissue thickness can also be determined by timing theduration until the MEMS light detection device senses light once theMEMS light producing device is turned on. If the MEMS light detectiondevice senses light, for example, at time t₀ after the MEMS lightproducing device is turned on, then anvil 320 and staple cartridgeassembly 318 are in close proximity or touching (small tissuethickness). If the MEMS light detection device senses light, forexample, at time t₀+t₁ after the MEMS light producing device is turnedon, then anvil 320 and staple cartridge assembly 318 are at apredetermined distance from each other. Also, if there is any tissueclamped between anvil 320 and staple cartridge assembly 318, then thetissue thickness is a predetermined tissue thickness. The predetermineddistance and tissue thickness can be determined by a processor accessingone or more look-up tables or other data structures and correlating themeasured time to distance and, then correlating the distance to tissuethickness.

Reference is made to commonly assigned U.S. Pat. Nos. 5,865,361,6,330,965 and 6,241,139 to Milliman et al., the entire contents of whichare incorporated herein by reference, for a more detailed explanation ofthe operation of surgical stapler 300.

Turning now to FIG. 4, an alternative embodiment of a surgical stapler,in accordance with the present disclosure, is shown generally as 400.Briefly, surgical stapler 400 includes a handle assembly 412 having atleast one pivotable actuating handle member 414 and an advancing member416 configured and adapted to open and close surgical stapler 400.Surgical stapler 400 further includes a tubular body portion 420extending from handle assembly 412, an annular staple cartridge assembly422 operatively connected to a distal end of tubular body portion 420,and an annular anvil 426 positioned opposite staple cartridge assembly422 and connected to surgical stapler 400 by a shaft 428. Staplecartridge assembly 422 includes a tissue contacting surface 422 a andanvil 426 includes a tissue contacting surface 426 a in juxtapositionrelative to tissue contacting surface 422 a of staple cartridge assembly422.

In accordance with the present disclosure, surgical stapler 400 includesa plurality of MEMS devices “M” provided at specific locations thereon.In particular, by way of example only and in no way is it to beconsidered as limiting, as seen in FIG. 4, at least one MEMS device “M”can be provided preferably on tissue contacting surface 426 a of anvil426, tissue contacting surface 422 a of staple cartridge assembly 422,on shaft 428 and/or on handle assembly 412.

As described above, MEMS devices “M” enable the measurement of variousparameters of surgical stapler 400, such as, for example, the distancebetween tissue contacting surfaces 422 a and 426 a of surgical stapler400, as well as the amount of pressure applied to tissue clamped betweentissue contacting surfaces 422 a, 426 a of surgical stapler 400.

Reference is made to commonly assigned U.S. Pat. No. 5,915,616 to Violaet al., the entire content of which is incorporated herein by reference,for a more detailed explanation of the operation of surgical stapler400.

While MEMS devices for determining distance and/or pressure are shownlocated at certain discrete positions on the structural elements of thesurgical staplers shown in FIGS. 1-4, it is within the scope of thepresent disclosure that MEMS devices for determining distance and/orpressure can be positioned anywhere on the structural elements of thesurgical staplers.

In FIGS. 1-4, MEMS devices “M” are merely located at representativepositions and are not intended to be indicative of the only positionswhere MEMS devices “M” can be provided or the numbers of MEMS devices“M” that can be provided. It is envisioned that a staple cartridgeholding component of the surgical stapler, including a staple cartridge,can be automatically or manually moved away from an anvil if thepressure applied to the clamped tissue is above a predeterminedthreshold. The surgical stapler can also be automatically or manuallyprevented from being fired in response to the feedback provided by MEMSdevices “M”. The feedback provided by MEMS devices “M” could be in theform of feedback signals (e.g., audio, visual and/or audiovisual),and/or in the form of mechanical feedback (e.g., a tactile indication).

The surgical staplers disclosed herein can be fitted withdifferent-sized surgical staples (i.e., staples having varying lengthlegs) and can be adapted to automatically select the proper sizedstaples for performing a or the particular surgical procedure accordingto information obtained by the MEMS devices “M”.

Turning now to FIGS. 5 and 5A, in which like reference numerals identifysimilar or identical elements, a surgical instrument for placing clipsin laparoscopic or endoscopic procedures employing the novel features ofthe present disclosure is generally designated with the referencenumeral 450.

As seen in FIG. 5, surgical instrument 450 includes a handle portion 452having pivoting or movable handle 454 and stationary handle 456.Manipulation of handles 454, 456 actuates a tool assembly, such as a jawassembly 458, through elongated body 460 which extends distally fromhandle portion 452. Elongated body 460 is preferably rotatable withrespect to handle portion 452 by turning knob 459. Jaw assembly 458includes first and second juxtaposed jaw portions 462 a, 462 b,respectively, which are simultaneously movable between a substantiallyapproximated position, in which jaw portions 462 a and 462 b are inrelatively close relation to one another, and a spaced position, inwhich jaw portions 462 a and 462 b are separated at least a sufficientdistance to receive an unformed surgical clip 464 (see FIG. 5A)therebetween.

It is envisioned that a plurality of surgical clips 464 are stored in aloading unit 466 which is releasably mounted to elongated body 460. In apreferred embodiment, loading unit 466 is disposable (i.e., in the formof a disposable loading unit or “DLU”) subsequent to depletion of thesupply of surgical clips 464 stored therein. The remainder of surgicalinstrument 450 may be disassembled, resterilized and reused incombination with another loading unit containing a supply of surgicalclips 464.

In use, approximation of movable handle 454 toward stationary handle 456results in the advancement of a distal-most surgical clip 464 to aposition between jaw portions 462 a and 462 b. Further approximation ofhandles 454, 456 toward one another results in the approximation of jawportions 462 a and 462 b toward one another to form the surgical clipdisposed therebetween.

In accordance with the present disclosure, surgical instrument 450includes a plurality of MEMS devices “M” provided at specific locationsthereon. In particular, by way of example only and in no way is it to beconsidered limiting, as seen in FIGS. 5 and 5A, at least one MEMS device“M” can be provided preferably on the tissue contacting surface of atleast one, preferably each, jaw portion 462 a, 462 b of jaw assembly458, on loading unit 466 and/or elongated body 460, and/or on handleportion 452.

As described above, MEMS devices “M” enable the measurement of variousparameters of surgical instrument 450, such as, for example, thedistance between the tissue contacting surfaces of jaw portions 462 a,462 b, as well as the amount of pressure applied to tissue clampedbetween jaw portions 462 a, 462 b. It is further envisioned that MEMSdevices “M” are capable of measuring and/or determining a thickness ofthe tissue clamped between tissue contacting surfaces of jaw portions462 a, 462 b.

Reference is made to commonly assigned U.S. Pat. No. 6,059,799 to Aranyiet al., the entire content of which is incorporated herein by reference,for a more detailed explanation of the operation of surgical instrument450.

Turning now to FIGS. 6 and 6A, in which like reference numerals identifysimilar or identical elements, a surgical instrument employing the novelfeatures of the present disclosure is generally designated with thereference numeral 500.

As seen in FIG. 6, surgical instrument 500 includes a housing 512 havinga fixed handle portion 514, a movable handle portion 516, an elongatedshaft 518 extending distally from housing 512, and a jaw mechanism 522operatively coupled to a distal end of shaft 518. As seen in detail inFIG. 6A, jaw mechanism 522 includes a pair of jaw members 580, 582 whichare pivotable about pin 519 in order to provide the opening and closingof jaw mechanism 522. Surgical instrument 500 is configured and adaptedsuch that, in operation, manipulation of movable handle portion 516,distally and proximally, relative to fixed handle portion 514, causesjaw members 580, 582 of jaw mechanism 522 to open and close. Jaw members580, 582 are shown as being configured and adapted to perform anelectrosurgical function, such as, for example, coagulation,cauterization and the like.

Jaw mechanism 522 can be configured to grasp, staple, cut, retract,coagulate and/or cauterize. The above examples are merely intended to beillustrative of a few of the many functions which jaw mechanism 522 canbe configured to accomplish and in no way is intended to be anexhaustive listing of all of the possible jaw or like or pivotablestructures.

As further shown in FIG. 6A, jaw mechanism 522 is provided with aplurality of micro-electrosurgical system (MEMS) devices “M” placed atspecific desired locations on, in or along the surfaces of jaw members580, 582. For example, MEMS devices “M” can be placed near a proximalend and/or near a distal end of jaw members 580, 582, as well as alongthe length of jaw members 580, 582.

In one preferred embodiment of the present disclosure, MEMS devices “M”offer a solution for controlling the amount of energy delivered, byradio frequency (e.g., monopolar or bipolar), ultrasonic, laser, argonbeam or other suitable energy systems, to tissue during treatment withenergy based electrosurgical instruments, for example, electrocauterysurgical instruments. In electrocautery surgical instruments the degreeof tissue cutting, coagulation and damage are influenced by the powersetting, the force applied by the jaw mechanism of the electrocauterysurgical instrument to the tissue, the duration of contact between thejaw mechanism of the electrocautery surgical instrument and the tissue,as well as other factors.

Accordingly, it is contemplated that energy sensing MEMS devices “M”,capable of measuring and/or sensing energy, be used to monitor, control,measure and/or regulate the amount of energy delivered by surgicalinstrument 500 to the tissue. Energy sensing MEMS devices “M” canprovide feedback to electronics within the electrocautery instrument,for example, to create a more consistent desired tissue effect. Inparticular, it is envisioned that selected MEMS devices “M” areconfigured and adapted to be force and/or pressure sensing MEMS devicesso that a pressure or a gripping force applied to the tissue by jawmembers 580, 582 can be sensed and regulated.

It is further envisioned that selected MEMS devices “M” can beconfigured and adapted to measure temperature on or near an active blade(not shown) of surgical instrument 500 (i.e., an electrocauteryinstrument, electrosurgical pencil, etc.). These temperature sensingMEMS devices “M” can be used to monitor and control the temperature ofthe active blade of the electrocautery instrument, such that the activeblade is able to reach and maintain a specific temperature, for example,by having intermittent bursts of energy supplied to the active blade orby controlling the power or energy delivered to the active bladewhenever the temperature of the active blade drops below a certainthreshold level.

In one embodiment, it is envisioned that these temperature sensing MEMSdevices “M” can be thermocouples positioned directly on a probe or aninstrument and electrically and thermally insulated from the same forthe sensing and/or measuring the temperature of tissue located adjacentthereto. It is further contemplated that, due to their relativelysmaller size and sensitivities, temperature sensing MEMS devices “M” canbe positioned on and/or encapsulated in thermally conductive tips orelements that could be semi-rigid wires or wires made of shape memorymetals for a particular application that could be extended out from theprobe and into the tissue adjoining a treatment probe in order tomonitor the temperature of the tissue adjoining the treatment probe.

It is further contemplated that selected MEMS devices “M” are configuredand adapted to be current sensing MEMS devices for regulating andmonitoring electrical current delivered to the active blade and throughthe tissue. It is envisioned that the flow or amount of current could beregulated to stop after delivery of a specific amount of energy or afterreaching a specific current value.

In addition, it is contemplated that selected MEMS devices “M” areconfigured and adapted to control the energy treatment by detecting thedistance between moveable elements, such as, for example, jaws havingelectrodes, in order to maintain the jaws at an optimal distance for oneor more aspects of a given treatment application. For example, distancesensing MEMS devices “M” can be employed to use light beams emitted fromlaser diodes and/or guided through fiber optics in conjunction with adetecting device, such as, for example, a bicell or a photo diodepositioned directly on the tip of the probe or at a remote locationsuitable for measuring the relative distance between portions of thejaws.

In an alternative embodiment of the present disclosure, it is envisionedthat MEMS devices “M” are configured and adapted to be accelerometerMEMS devices “M”, which accelerometers detect frequencies bydisplacement of a cantilevered or tuned element associated with MEMSdevices “M”. Accordingly, when the surgical instrument is an energybased surgical instrument, for example, of the cutting or coagulatingtype (e.g., electrosurgical instrument) which includes a jaw mechanism522 as described above, MEMS devices “M” employing suitable sensors canbe employed for measuring the acceleration and displacement of jawmembers 580, 582 in relation to each other. Accordingly, accelerometerMEMS devices “M” can be positioned on individual components, such as,for example, each jaw 580, 582, to measure their relative acceleration,on the overall surgical instrument 500 or on a fixed blade whichperforms the coagulating and cutting functions, such as, for example, anelectrosurgical pencil to measure the acceleration of the instruments awhole, or a combination thereof.

When accelerometer MEMS devices “M” are employed and suitably integratedas two or three orthogonal assemblies, they effectively constitute atwo-dimensional or three-dimensional acceleration measuring device orgyroscope type device when provided with a known point of originationand appropriately configured computer system. In this embodiment, MEMSdevices “M” can be advantageously employed as a passive system fortracking the distance between the jaws, position of the instrumentrelative to the target tissue portion and duration of treatment.

A further application for MEMS devices “M” in surgical instruments suchas electrosurgical cutting or coagulating devices includes torquesensing. It is contemplated that selected torque sensing MEMS devices“M” can be properly positioned on each jaw member 580, 582, on jawmechanism 522 or on a combination of both. Torque sensing MEMS devices“M” can be configured and adapted to employ strain sensors or opticalmeasuring systems, for example. It is envisioned that, torque sensingMEMS devices “M” can be configured to detect the deflection at differentpoints along the element or handle of the instrument relative to oneanother. Accordingly, the deflection of portions of the surgicalinstrument, at predetermined points and angles of application of torquesensing MEMS devices “M”, could be equated to an applied force ortorque. Strain sensors or fiber optic or integrated waveguide structurein conjunction with a detection system could be used to detect, measureand control the degree of force applied to or exerted by components bymonitoring the relative changes in distance or deflection of portions ofthe instrument.

Preferably, as seen in FIG. 6, MEMS devices “M” are electrically coupledto a control box 562 via wire leads 560 extending from housing 512. Itis envisioned that wire leads 560 travel through housing 512 and shaft518 to MEMS devices “M”. In a preferred embodiment, MEMS devices “M” andcontrol 562 box are electrically coupled to a feedback circuit (notshown). The feedback circuit would continually monitor and transmitsignals and parameters between MEMS devices “M” and control box 562.

MEMS devices “M”, such as those described above, may also be employedindividually or in combination with traditional sensor systems, such as,for example, loss detection circuitry between elements of theinstrument, and can be suitably configured to provide feedback to anelectronic control system (e.g., computer, microprocessor, programmablelogic controller or combination thereof) for tracking each reportedfeedback parameter relative to predefined criteria for the automaticadjustment and control of the energy delivered by the instrument inorder to, e.g., measure, determine, verify and/or control theeffectiveness of the treatment and proper performance of the surgicalinstrument. The control system would preferably also be configured withlogic to weight the inputs of each parameter sensed by a MEMS device “M”and accommodate the selective manual operation of any parameter. Thus,parameters of MEMS devices “M” may be integrated into a singlecomputerized display system or separately monitored, for example, by thedisplay system or by simple audible, visual or tactile warning systems.The control system could be integrated at least partially into theinstrument or a separate system connected to the instrument.

By way of example only, in accordance with the present disclosure, it isenvisioned that the MEMS devices “M” can include pressure measuringdevices (i.e., capacitive, piezoresistive, piezoelectric, resonantand/or optical fiber interferometric, etc.), strain measuring devices(i.e., piezoresistive, piezoelectric and/or frequency modulation, etc.),displacement measuring devices (i.e., capacitive, magnetic and/oroptical fiber interferometric), optical (i.e., fluorescence, absorptionand/or optical fiber interferometric), biosensors (for measuring, i.e.,glucose, neural probes, tactile, pH, blood gases) and/or immunosensors,temperature sensors, torque sensors, accelerometers, flow sensors andelectrochemical and/or electromagnetic sensors, and combinations of theabove.

In accordance with the principles of the present disclosure, as seen inFIGS. 7-12, it is envisioned that the above described surgicalinstruments, together with their respective incorporated MEMS devices“M” can be employed with or interface directly with a robotic surgicalsystem 600. An exemplary robotic surgical system is disclosed incommonly assigned U.S. Pat. No. 6,231,565 to Tovey et al., the entirecontents of which is incorporated herein by reference.

Generally, robotic surgical systems include surgical instrument orsystems, either powered locally or remotely, having electronic controlsystems localized in a console or distributed within or throughout thesurgical instrument or system. The surgical instrument systems can bepowered and controlled separately from the robotic system or, in thealternative, the power and control systems can be integrated orinterfaced with the robotic surgical system.

In particular, as seen in FIG. 7, robotic surgical system 600 includesan actuation assembly 612, a monitor 614, a robot 616 and a loading unit618 releasably attached to robot 616 and having at least one surgicalinstrument 620 for performing at least one surgical task operativelyconnected thereto. Robot 616 includes a trunk 622 extending from a base624, a shoulder 626 connecting trunk 622 to an upper arm 628, an elbow630 connecting upper arm 628 to a lower arm 632, and a wrist 634attached to lower arm 632 from which extends a mounting flange 636.Preferably, mounting flange 636 is capable of moving in six degrees offreedom.

As used herein, “loading unit” is understood to include disposableloading units (e.g., DLU's) and single use loading units (e.g., SULU's).SULU's include removable cartridge units, e.g., for opengastrointestinal anastomosis and transverse anastomosis staplers andinclude removable units, e.g., those having a shaft 316, a cartridgeassembly 318 and an anvil 317 (see, e.g., FIG. 3 hereof). These latterremovable units, which can be modified, are sometimes referred to asDLU's (e.g., see 618 in FIGS. 7 and 718 in FIG. 9).

Disposable loading unit 618 further includes a head portion 640 forhousing an electro-mechanical assembly 619 (see FIG. 8) therein foroperating surgical instrument 620 and an attachment platform 642 forreleasably attaching disposable loading unit 618 to robot 616 viamounting flange 636. Mounting flange 636 preferably includes two slots635 which inter-engage with protrusions 638 of platform 642 to connectto mounting flange 636 with disposable loading unit 618. It is furthercontemplated that an electrical connection 633 (see FIG. 8) be providedbetween slots 635 and protrusions 638 in order to provide power toelectro-mechanical assembly 619.

Disposable loading unit 618, which could be a surgical instrument ascontemplated herein, can be removed from mounting flange 636 and bereplaced with another such disposable loading unit, or surgicalinstrument, for performing a different surgical procedure. By way ofexample only and in no way to be considered as limiting, potentialsurgical instruments or systems which can interface with robotic system600 include various hand instruments, e.g., graspers, retractors,specimen retrieval instruments, endoscopic and laparoscopic instruments,electrosurgical instruments, stapling or fastener applying instruments,coring instruments, cutting instruments, hole-punching instruments,suturing instruments and/or any combination thereof. It is envisionedthat each of these instruments be provided with at least one, preferablya plurality of MEMS devices “M” as described above, for providingfeedback to the user. It is further contemplated that MEMS devices “M”can provide feedback directly to robotic system 600 in order for roboticsystem 600 to respond, e.g., adapt in response to the feedback and/orprovide notification to the user of robotic system 600. It is furtherenvisioned that a plurality of sensors can be incorporated into, e.g.,provided on an energy based surgical instrument, which energy basedsurgical instrument can also be interfaced with robotic system 600.Accordingly, the energy provided to the energy based surgical instrumentcan be delivered and controlled directly by robotic system 600 forimproved user interfaces and better system integration.

In operation, the user (e.g., surgeon, nurse, technician, etc.) controlsactuation assembly 612 to control the movement and operation of robot616 and disposable loading unit 618. Depending on the amount of rotationof knobs 644 on actuation assembly 612, actuation assembly 612 transmitselectrical signals to robot 616 to electro-mechanically operate themoveable parts of robot 616, such as to rotate robot 616 about verticaltrunk 622 or to advance mounting flange 636. Actuation assembly 612 mayinclude a processor therein for storing operational commands and fortransmitting digital signals to electro-mechanical assembly 619.Actuation assembly 612 can also transmit electrical signals to mountingflange 636 in the form of electrical signals, for example, forpositioning and operating loading unit 618.

Actuation assembly 612 preferably is adapted to transmit electricalsignals to an electro-mechanical assembly 619 housed within head portion640 of loading unit 618 for actuating electro-mechanical assembly 619which in turn actuates surgical instrument 620. Electro-mechanicalassembly 619 includes mechanisms for moving and operating surgical toolinstrument 620, such as, for example, servo motors for harmonicallyoscillating a scalpel of a cutting instrument, or rods for pivotallymoving a suturing needle positioned on an axis of a longitudinal casingof a suturing instrument.

As seen in FIG. 8, disposable loading unit 618 may further includeintegrated circuitry for receiving digital signals from actuationassembly 612, such as, for example, a receiver 621 and a processor 623.Receiver 621 and processor 623 are included within control means 625electrically connected to electro-mechanical assembly 619.

By way of example only, as shown in FIG. 9, a disposable loading unit718, hereinafter sometimes referred to as loading unit 718, including anend effector of a surgical stapler, similar to the end effector ofsurgical stapler 100 described above, is operatively connected to robot616 (see FIG. 7) such that an array of surgical fasteners (e.g.,staples) can be applied to body tissue. In particular, loading unit 718includes a distally extending body portion 716, a transverse bodyportion 715, and support frame 719 operatively received in a distal endof transverse body portion 715. Loading unit 718 further includes ananvil 720 and a staple cartridge assembly 722 operatively receivedwithin transverse body portion 715. Each of anvil 720 and staplecartridge assembly 722 include juxtaposed tissue contacting surfaces 720a, 722 a, respectively.

It is envisioned that loading unit 718 includes an actuator incorporatedwithin a head portion 792 to perform fast closure and incrementaladvancement of staple cartridge assembly 722 with respect to anvil 720.As described above, relative to surgical stapler 100, MEMS devices “M”can be provided on anvil 720 and staple cartridge assembly 722 toprovide feedback information to robot 616.

Examples of direct information that can be fed back to robot 616 fromMEMS devices “M” of loading unit 718 or other MEMS devices include, forexample, whether staples have been fired or, in the case of anelectrosurgical instrument, the amount of energy delivered. MEMS device“M” can also be used to make indirect measurements of performance, suchas, for example, detecting the status of staple firing by measuring theposition of the assembly member responsible for pushing the staples outof the cartridge. Alternatively, MEMS devices “M” can measure anassociated member, such as a displacement of a drive rod or a rotationof a screw rod to determine whether the staples have been fired or not.In either instance, robotic system 600 can accept the information fromloading unit 718 and respond accordingly, for example, by eitheraltering performance, making adjustments, notifying the user, modifyingor stopping operation or any combination thereof.

Reference is made to commonly assigned U.S. Pat. No. 5,964,394 toRobertson, the entire content of which is incorporated herein byreference, for a more detailed explanation of the operation and internalworking of the components of the end effector of the surgical stapleroperatively coupled to the distal end of loading unit 718.

As seen in FIG. 10, a loading unit including a distal end portioncapable of performing an electrosurgical function, similar to surgicalinstrument 500 above, is shown generally as 800. In particular, loadingunit 800 includes a head portion 802 configured and adapted to beremovably coupled to mounting flange 636 of robot 616, an elongate shaft818 extending distally from head portion 802, and a jaw mechanism 822operatively coupled to a distal end of shaft 818. Jaw mechanism 822includes a pair of jaw members 880, 882 which are pivotable about pin819 in order to provide the opening and closing of jaw mechanism 822.Jaw members 880, 882 are preferably configured and adapted to perform anelectrosurgical function, such as, for example, coagulation,cauterization and the like.

Loading unit 800 is preferably further provided with MEMS devices “M”placed near a proximal end, a distal end, approximately mid-way and/orall along the length of each jaw member 880, 882 in order to providefeed back information to robot 616. Accordingly, in the case of loadingunit 800, MEMS devices “M” can feed back, to robot 616 and actuationassembly 612, information regarding, for example, the amount of energydelivered, the clamping force being applied by jaw members 880, 882, thetemperature at the target surgical site and the like.

Turning now to FIG. 11, a loading unit including a vessel clip applyingend effector, for applying surgical clips to body tissue, for example,for occluding vessels, is shown generally as 900. Loading unit 900includes a head portion 902, a body portion 904 extending distally fromhead portion 902, and a plurality of surgical clips (not shown) disposedwithin body portion 904. A jaw assembly 906 is mounted adjacent a distalend portion 908 of body portion 904. Jaw assembly 906 includes a firstand a second jaw portion 910 a, 910 b, respectively, which are movablebetween a spaced-apart and approximated position relative to oneanother.

A clip pusher (not shown) is provided within body portion 904 toindividually distally advance a distal-most surgical clip to jawassembly 906 while first and second jaw portions 910 a, 910 b are in thespaced-apart position. An actuator 912, disposed within body portion904, is longitudinally movable in response to actuation ofelectro-mechanical assembly 619 provided within head portion 902. A jawclosure member 914 is positioned adjacent first and second jaw portions910 a, 910 b to move jaw portions 910 a, 910 b to the approximatedposition. Actuator 912 and jaw closure member 914 define an interlocktherebetween to produce simultaneous movement of actuator 912 and jawclosure member 914 when actuator 912 is positioned adjacent the distalend portion of body portion 904.

It is envisioned that loading unit 900 preferably includes at least oneMEMS device “M” operatively connected to each of the first and secondjaw portions 910 a, 910 b to provide feedback information to robot 616.

Reference is made to commonly assigned U.S. Pat. No. 6,059,799 to Aranyiet al., the entire content of which is incorporated herein by reference,for a more detailed explanation of the operation and internal working ofthe components of the vessel clip applying end effector of loading unit900.

Turning now to FIG. 12, a loading unit including a vascular sutureapplying end effector, for suturing vascular tissue sections together,is shown generally as 950. Loading unit 950 includes a head portion 952and a body portion 954 extended distally therefrom. A pair of needlereceiving jaws 956, 958 are pivotally mounted at a distal end of bodyportion 954 and are configured to repeatedly pass a surgical needle 960and associated length of suture material therebetween. Loading unit 950further includes needle holding structure (not shown) mounted withinjaws 956 for reciprocal movement into and out of needle holding recesses962 formed in jaws 956, 958. During an anastomosis procedure, loadingunit 950 will advantageously respond to movement commands transmittedfrom the actuation assembly to apply fasteners to tissue.

It is envisioned that loading unit 950 preferably includes at least oneMEMS device “M” operatively connected to each of the pair of needlereceiving jaws 956, 958 to provide feedback information to robot 616. Itis contemplated that MEMS device “M” can, for example, provideinformation relating to the position of jaws 956, 958, whether and inwhich jaw needle 960 is disposed, and the force being exerted on needle960.

Reference is made to commonly assigned U.S. Pat. No. 5,478,344 to Stoneet al., the entire content of which is incorporated herein by reference,for a more detailed explanation of the operation and internal working ofthe components of the vascular suture applying end effector of loadingunit 950.

An advantage of using MEMS devices in conjunction with robotic systems,similar to those described above, is that conditions and forces sensedby the MEMS devices provided on the end effectors of the loading unitscan be fed back system to the robotic systems or transmitted to a userinterface.

Current robotic systems allow little to no tactile information to reachor be transmitted from the patient back to the hands of the user (i.e.,the surgeon). Accordingly, by using MEMS devices, in accordance with thepresent disclosure, in combination with a feedback and control system,conditions and forces experienced by the distal end of the end effectorsdue to the interaction of the end effector with the tissue of thepatient can be “felt” and/or monitored by the surgeon, thus greatlyimproving the surgeon's information and, in turn, ability to performsurgical procedures.

In accordance with the present disclosure, it is contemplated to havefeedback of information, data, signals, conditions and forces, initiatedby pressure and/or other parameters indicative of the surgical taskbeing performed by the end effector of the disposable loading unit andmeasured and/or sensed by MEMS devices provided on the loading unit, andto transmit this feedback to a control system. This feedback controlsystem allows the robotic system to be programmed, before the surgicaltask is performed, with guidance, pressure, and other parameters whichcan be continuously monitored to control the operation and movement ofthe loading unit and of the associated end effector.

Although the illustrative embodiments of the present disclosure havebeen described herein, it is understood that the disclosure is notlimited to those precise embodiments, and that various other changes andmodifications may be affected therein by one skilled in the art withoutdeparting from the scope or spirit of the disclosure. All such changesand modifications are intended to be included within the scope of thedisclosure.

1-69. (canceled)
 70. A robotic system for performing surgical tasks, therobotic system comprising: a frame; a robotic arm connected to the frameand movable in six degrees of freedom relative to the frame via amounting flange; an actuation assembly operatively associated with therobotic arm for controlling operation and movement of the robotic arm,the actuation assembly including a processor for storing operationalcommands; a loading unit including an elongate shaft releasablyconnected to the robotic arm, and a surgical stapler operatively coupledto a distal end of the elongate shaft and configured to engage tissue,the loading unit including a head portion for housing anelectro-mechanical assembly configured to receive signals from theprocessor of the actuation assembly, and the loading unit connected tothe mounting flange via one or more protrusions of the frameinterconnecting with one or more slots of the mounting flange; and atleast one micro-electromechanical system (MEMS) device operativelyconnected to the loading unit for at least one of sensing a condition,measuring a parameter and controlling the condition and/or parameteradjacent an end effector of the surgical stapler; wherein the surgicalstapler includes a staple cartridge assembly and an anvil operativelyassociated with the staple cartridge assembly and in juxtapositionrelative to the staple cartridge assembly, such that the at least oneMEMS device is operatively connected to each of the staple cartridgeassembly and the anvil; wherein a plurality of discrete MEMS devices areselectively disposed from a proximal end to a distal end of the surgicalstapler on the following portions of the surgical stapler: (i) a firstend and a second end of the anvil (ii) a first end and a second end ofthe staple cartridge assembly, (iii) a body member, and (iv) a handleassembly; and wherein each MEMS device of the plurality of discrete MEMSdevices is a single integral device disposed on a separate substratethat is operationally independent of other MEMS devices configured tocommunicate with the surgical stapler, the MEMS devices including two orthree orthogonal assemblies of MEMS devices integrated together to forma two or three dimensional acceleration measuring device adapted todetect frequencies by displacement of a cantilevered or tuned elementassociated with each MEMS device.
 71. The robotic system of claim 70,wherein the at least one MEMS device is selected from the groupconsisting of a pressure sensor, a strain sensor, a displacement sensor,an optical sensor, a biosensor, a temperature sensor, a torque sensor,an accelerometer, a flow sensor, an electrical sensor and a magneticsensor, for at least one of sensing, measuring and controlling anassociated condition and/or parameter.
 72. The robotic system of claim70, wherein the loading unit is connected to the robotic arm via abayonet-type connection.
 73. The robotic system of claim 70, wherein thesurgical stapler is configured and adapted to perform an electrosurgicalfunction.
 74. The robotic system of claim 70, wherein the surgicalstapler is configured and adapted to deliver electrosurgical energy to atarget surgical site.
 75. The robotic system of claim 70, furthercomprising a controller including a receiver for receiving electricalsignals transmitted from the actuation assembly and for controllingoperation and movement of the loading unit.
 76. The robotic system ofclaim 70, wherein the surgical stapler is selected from a groupconsisting of a fastener applier, a surgical stapler, a vessel clipapplier, and a vascular suturing assembly.
 77. The robotic system ofclaim 70, wherein the staple cartridge assembly defines a tissuecontacting surface and wherein at least one MEMS device is operativelyconnected to a tissue contacting surface of the staple cartridgeassembly.
 78. The robotic system of claim 77, wherein the anvil definesa tissue contacting surface and wherein at least one MEMS device isoperatively connected to the tissue contacting surface of the staplecartridge assembly.
 79. The robotic system of claim 78, wherein the MEMSdevices are configured and adapted to measure distance between thetissue contacting surface of the staple cartridge assembly and thetissue contacting surface of the anvil.
 80. The robotic system of claim78, wherein the MEMS devices are configured and adapted to measure theamount of pressure applied to tissue clamped between the tissuecontacting surface of the staple cartridge assembly and the tissuecontacting surface of the anvil.
 81. The robotic system of claim 70,wherein the staple cartridge assembly and the anvil are transverselyoriented with respect to the elongate shaft.
 82. The robotic system ofclaim 70, wherein the staple cartridge assembly and the anvil arepivotably connected to the distal end of the elongate shaft.
 83. Therobotic system of claim 70, wherein the end effector is a vascularsuturing assembly, the vascular suturing assembly comprising: anelongate body having a distal end and a proximal end, wherein theproximal end in operatively connectable to the robotic arm; and a pairof needle receiving jaws pivotably mounted to the distal end of theelongate body portion, the pair of needle receiving jaws beingconfigured and adapted to pass a surgical needle and associated lengthof suture material therebetween.
 84. The robotic system of claim 83,further including at least one MEMS component operatively connected toeach of the pair of needle receiving jaws.
 85. The robotic system ofclaim 70, wherein at least one control operation of the surgical stapleris automatically adjusted based on feedback received from the at leastone MEMS device via at least one comparator for comparing at least oneof a second condition and a measured parameter against at least onepredetermined value.
 86. The robotic system of claim 70, furthercomprising a feedback control system configured to allow the roboticsystem to be programmed, before a surgical task is performed, tocontinuously monitor, in real-time, a plurality of parameters andoperations associated with movement of the loading unit and the endeffector of the surgical stapler.
 87. The robotic system of claim 70,wherein the at least one MEMS device is a wireless transmitter.
 88. Therobotic system of claim 70, wherein the at least one MEMS deviceincludes one or more transducer delivery and receiving devices.